Guidelines: ALJ Decisions in FDA Cases Under 21 C.F.R. Part 17
The Code of Federal Regulations (C.F.R.) Title 21, Part 17, and the sections of the Federal Food, Drug, and Cosmetic Act, and the Public Health Service Act cited therein, authorize the Food and Drug Administration (FDA) to impose civil money penalties on individuals or entities, based on certain determinations. An individual or entity affected by such a determination is entitled to a hearing by an Administrative Law Judge (ALJ) under the procedures at 21 C.F.R. Part 17. A dissatisfied party may request review of the ALJ decision by the Departmental Appeals Board (Board) in accordance with the procedures in 21 C.F.R. § 17.47. These guidelines have been designed to assist the parties in understanding and following the procedures relating to Board review.
If you have any questions about these guidelines, you may call Appellate Division attorney Carolyn Reines-Graubard at (202) 565-0116.
Starting the Review Process
(a) Under 21 C.F.R. §§ 17.17 and 17.47(a), either party dissatisfied with an ALJ's initial decision or a decision granting summary decision on all issues may appeal that decision to the Board. The Board may hear an interlocutory appeal of a ruling by the ALJ only if the ALJ certifies that immediate review is necessary to prevent exceptional delay, expense, or prejudice to any participant, or substantial harm to the public interest. See 21 C.F.R. § 17.18(b).
(b) An affected individual or entity has a right to be represented before the Board, at the individual's or entity's own expense, by an attorney or someone else. A representative should file with the Board a signed statement that he or she has been authorized to represent the affected individual or entity, unless the same representative appeared in the proceedings before the ALJ.
(c) Your notice of appeal must be filed within 30 days of the date that the ALJ issues a decision unless you make a written request for an extension which the Board grants for good cause shown. Any request for an extension must be filed within the initial 30-day period and should explain why there is good cause for the requested extension, which may not exceed 30 days. If an ALJ decision is served by mail, it is deemed to be issued five days after it is placed in the mail. See 21 C.F.R. §§ 17.47(b)(1) and 17.30(c).
(d) Your notice of appeal must be accompanied by a written brief specifying each finding of fact and conclusion of law with which you disagree, and your basis for contending that each such finding or conclusion is unsupported or incorrect. The Board expects that the basis for each challenge to a finding or conclusion in the ALJ decision will be set forth in a separate paragraph or section, and that the accompanying arguments will be concisely stated. In addition, where appropriate, each argument should be supported by precise citations to the record and/or by precise citations to statutes, regulations or other relevant authorities upon which you are relying. The written brief should not exceed 30 pages or any greater length allowed by the ALJ for the posthearing brief pursuant to 21 C.F.R. § 17.47(c).
Filing Requirements for All Submissions
(a) All submissions should be filed with both of the following:
Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane, Room 1061, HFA-305
Rockville, MD 20852
Department of Health and Human Services
Departmental Appeals Board, MS 6127
330 Independence Ave., S.W.
Cohen Building, Room G-644
Washington, D.C. 20201
(b) A submission is considered "filed" with the Board on the postmark date, the date sent by registered or certified mail, the date deposited with a commercial delivery service, or the date a fax (where permitted) is sent. Please do not fax a submission if it is over 10 pages. Faxes should be sent to (202) 565-0238.
(c) If the last day of the period for filing a submission falls on a federal nonworkday (a Saturday, Sunday, legal holiday, or a day which by statute or Executive Order is declared to be a nonworkday for federal employees), the submission may be filed on the next federal workday.
(d) Both parties should provide an original and two copies of all submissions to the Board and a copy to the opposing party. (If your submission is faxed to the Board, the required two copies should be mailed.) Include in any submission a statement that you have sent a copy to the opposing party.
(e) The parties should not submit materials already submitted to the ALJ..
(f) A submission (including the request for review) may not incorporate by reference a brief or parts of a brief previously submitted to the ALJ.
Development of the Record on Appeal
(a) The notice of appeal is referred to a panel of three Board members, one of whom presides over the development of the record on appeal. The Presiding Board Member is assisted by a staff attorney whom the parties may contact if they have questions about case status or procedures.
(b) When the Board receives a notice of appeal, it will obtain the administrative record of the ALJ proceeding.
(c) The opponent of the party that filed the notice of appeal may submit a response, which may also raise any relevant issue not addressed in the notice of appeal. The response should not exceed 30 pages or any greater length allowed by the ALJ for the posthearing brief, and must be filed within 30 days after the opposing party receives a copy of the notice of appeal.
(d) The party that filed the notice of appeal may file a reply brief not more than 10 pages in length within 10 days of the date of service of the opposing party's brief. If the opposing party's brief is mailed to you, the date of service is deemed to be five days from the date of mailing.
(e) The Board expects any party needing an extension for filing the response or the reply (or any additional submission required by the Board) to file a request for an extension before the original due date, to include a statement about whether the opposing party objects to the requested extension, and to state the reasons for the request. The Board will grant an extension only for good cause shown.
(f) The Board may ask for additional briefing if it considers issues not adequately briefed by the parties. Additional briefs will not, however, be considered unless the Board requests them. See 21 C.F.R. § 17.47(h).
(g) On rare occasions, the Board may grant a request for oral argument if the Board determines that oral argument would facilitate its decisionmaking. A party wishing to appear before the Board to present oral argument should request such an opportunity no later than the time for filing its last submission provided for in (c) or (d) above and should state the purpose of the requested appearance. Generally, any oral proceeding will be conducted by the Presiding Board Member by telephone conference rather than in person.
Procedures for Interlocutory Appeals
(a) A party wishing to file an interlocutory appeal must obtain a certification from the ALJ that immediate review is necessary to prevent exceptional delay, expense, or prejudice to any participant, or substantial harm to the public interest. The ALJ's certification must be made on the record or in writing. The certification must specify the deadline for filing an interlocutory appeal. The certification may also authorize the party filing the interlocutory appeal to submit a brief in support of the appeal at a time set by the ALJ or to be set by the Board.
(b) The interlocutory appeal must be filed with the Board by the deadline specified in the ALJ's certification and must include a copy of the ALJ's certification. The appeal must specifically identify the determination made by the ALJ that is being appealed and should include a copy of the ALJ's partial summary decision, ruling, order or other document setting out this determination. The interlocutory appeal may not exceed three pages (not including the copy of the ALJ's determination).
(c) If the certification does not authorize the party filing the interlocutory appeal to submit a brief in support of the appeal, that party may request that the Board authorize the submission of such a brief. Upon receipt of an interlocutory appeal, the Board will rule on any request to submit a brief in support of the appeal and set a time for the submission of any brief authorized by it, or set a time for the submission of any brief authorized by the ALJ for which no such time has been specified. In setting such a time, the Board will consider any estimate by the filing party of the time needed to prepare the brief and the impact of any delay in the proceedings before the ALJ.
(d) The opposing party may submit a brief in response to any brief in support of the interlocutory appeal. Unless otherwise specified by the Board, the opposing party's brief must be filed within 30 days of its receipt of the brief in support of the interlocutory appeal. No further briefs may be filed except at the request of the Board.
(e) The Board will, where appropriate, rule on the interlocutory appeal without reviewing the administrative record of the ALJ proceeding. If the ALJ does not stay the proceedings pending the interlocutory appeal, the Board may ask the parties to enter into a stipulation as to what documents in the administrative record are necessary for the Board's review and to provide a copy of those documents.
Completion of the Review Process
(a) The Board will review only those parts of the record before the ALJ which are cited by the parties or which the Board considers necessary to decide the appeal. The Board will consider only those issues raised before the ALJ, except that the opponent of the party that filed the notice of appeal may make any argument based on the record in support of the initial decision or decision granting summary decision. See 21 C.F.R. § 17.47(g).
(b) If a party demonstrates to the satisfaction of the Board that evidence not presented to the ALJ is relevant and material and that there were reasonable grounds for the failure to present it to the ALJ, the Board may remand the case to the ALJ for consideration of such additional evidence.
(c) The standard of review on a disputed factual issue is whether the initial decision is supported by substantial evidence on the whole record. The standard of review on a disputed issue of law is whether the initial decision is erroneous. See 21 C.F.R. § 17.47(k).
(d) The Board may decline review of the case, affirm or reverse the ALJ decision, or may affirm, increase, reduce, reverse or remand any penalty or assessment determined by the ALJ.
(e) If practicable, the Board will complete its review and issue a decision within 60 days after the time for the last submission permitted by the Board has expired. See 21. C.F.R. § 17.47(j).
(f) An affected individual or entity that is dissatisfied with the Board's decision and is entitled to judicial review may file a petition for judicial review according to the statutes governing the matter involved. If a petition for judicial review is filed, a copy of the filed petition must be sent by certified mail, return receipt requested, to the Chief Counsel of FDA. The administrative record is certified by the Board Chair and is filed with the court by the Chief Counsel of FDA.
Last Revised: 04/20/12